Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer

Abstract

This thesis performs a retrospective evaluation of data generated for the cytotoxic/cytostatic antimetabolite drug gemcitabine along the different phases of drug development. Using these data, and through data analysis and simulations-based translational exercise, a model-based framework in oncology, relating in vitro and in vivo pre-clinical pharmacokinetic (PK) and tumour size (TS) information, with response outcome obtained in clinical trials, has been developed.